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U.S. Department of Health and Human Services

Product Classification

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Device powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Description Infrared lamp.
Definition A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation.This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication.It does not provide therapeutic topical heating.The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeNHN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible